The common usage of dialyzing machines is now being partially replaced by a dialysis system which involves introducing dialyzing fluids into the peritoneal cavity of the body. In this system, an elongated tube is secured with a perforated end within the peritoneal cavity and the other end projecting through the epidermis. One or more flanges along the tube between the peritoneum and the epidermis are designed to provide biological barriers. Dialyzing fluid is introduced into the body by opening the external ends of the tube and passing a dialyzing fluid through the tube into the cavity for a time period and in quantities sufficient to permit contaminants from the blood to mix across the peritoneal membrane with the dialyzing fluid. The dialyzing fluid is then removed by siphon or a gravity technique and the procedure is repeated. This system is used for both acute and chronic dialysis problems. While the short term nature of an acute peritoneal dialysis procedure usually minimizes the problems usually inherent in this technique, chronic peritoneal dialysis does pose a number of problems which are not satisfied by the presently available techniques. In this prior art technique the dialyzing tube is normally secured to the fascia and the peritoneum by suturing a porous flange designed to provide a biological seal at the point at which the tube passes through the fascia and peritoneum. This system also provides, in many instances, a second biological seal at a position laterally spaced from the first and under the fat layers. The tube then exists through the epidermis where it is closed until required. This arrangement is frequently uncomfortable to a patient because the tube projects permanently from the patient's body at some point in the abdominal wall. In addition, this system poses a serious infection problem. The open end of the tube provides a permanent entrance site for possible infection. This, in turn, requires a great deal of care by the patient in making sure the tube is closed at all times when not in use. But even if the patient is careful, bacteria may enter the tube when hooking up the tube to the dialyzing fluid. The patient, moreover, must be especially careful when taking showers or swimming and, in many instances, will refrain from both of these activities in fear of introducing infection through the tube. There is also some basis for believing that bacteria pass down the outer wall of the tube and through the biological barriers before these biological barriers have been fully integrated with the surrounding tissue.
Since the portion of the tube projecting from the patient's body is normally held against the body with a bandage over a long period of time, there is always a potential source of localized skin problems caused by the adhesive bandage securing the tube end. Furthermore, this projecting tube also creates cosmetic and psychological problems for the patient. These psychological problems are particularly acute in patients with kidney problems that require many hours of dialysis every week for indefinite periods of time.
A further common complication in peritoneal dialysis using systems of this type is bleeding primarily from the abdominal wall. At times this requires additional suturing or transfusions. When bleeding is substantial, the catheter frequently becomes plugged. Peritonitis is also a common result of contamination of the tubing or from poor placement of the catheter. Consequent infection rates are occasionally as high as ten percent.
There is also some evidence of experimental efforts to provide subcutaneous peritoneal dialysis by embedding a tube and chamber under the skin. This arrangement involves the use of a tube extending into the peritoneal cavity with an elongated bulky rigid tube member secured subcutaoneously. This system appears to have been experimental and, if implanted, was proved unacceptable for a variety of reasons. The bulk and rigidity of the tube makes it difficult to implant and secure. It would also be very uncomfortable and likely to cause serious trauma to the patent because of its size, shape and rigidity.